ST. LOUIS, Oct 26, 2011 /PRNewswire/ -- Sigma-Aldrich
Corporation (NASDAQ: SIAL) today announced that its custom
manufacturing and services business unit, SAFC®
(www.safcglobal.com), has completed an assessment by SafeBridge®
Consultants, Inc. and has been granted SafeBridge Certification for
its commercial scale High-Potency Active Pharmaceutical Ingredients
(HPAPI) facility in Verona,
Wisconsin. As a widely accepted industry benchmark for
handling highly potent pharmaceuticals, the SafeBridge program
assessment focuses on four primary areas: management; hazard
identification and evaluation; hazard controls; and communication,
education and training.
Constructed at a cost of $30
million and officially opened in April 2010, the Verona site was built specifically to support
pharmaceutical manufacturers with their Phase III and commercial
HPAPI needs. The state-of-the-art facility is designed to increase
efficiencies and safe handling in high-potency production and to
adhere to Category IV standards, the highest guideline for HPAPI
handling and containment. The SafeBridge assessment, which also
included a successful recertification of SAFC's nearby Madison, Wisconsin high-potency facility, took
place over three days in September, 2011. The process included
review of health and safety programs, containment equipment testing
results, as well as appraisal of material handling and GMP
production areas.
"The latest SafeBridge Certification status for our Verona facility builds on successful
accreditations at our Madison HPAPI plant, which we originally
received in 2003, and our HPAPI bioconjugation suite in
St. Louis, which was awarded in
2009," commented Dave Bormett, SAFC
Director of Operations. "SafeBridge Certification reflects SAFC's
ongoing commitment to the safety of our staff, and to handle our
customers' potent compound projects safely and efficiently."
Over the last three years, SAFC has seen a continual increase in
the number of projects for HPAPIs and other high-potency
pharmaceutical services, including late stage projects that will
need commercial scale manufacturing. This demand is behind the
construction of the Verona
facility, which houses commercial scale reactors capable of
producing HPAPI batch sizes up to 4,000 liters and features
specially designed quality control laboratories, warehouse and
office space, including space for expansion.
While oncology is currently the main driver for HPAPI
development, SAFC has manufactured HPAPIs for indications beyond
the cancer field, including low-dose Vitamin D analogs for the
therapeutic areas of autoimmune and cardiovascular diseases. This
range of indications may continue to grow as additional potent
compounds are identified and developed in future years.
For more information, visit: www.safcglobal.com
The foregoing release contains forward-looking statements that
can be identified by terminology such as "may", "should", "designed
to", "believe" or similar expressions, or by expressed or implied
discussions regarding potential future revenues from products
derived there from. You should not place undue reliance on these
statements. There can be no guarantee that the products described
in this release will continue to meet the demands of the
marketplace. Nor can there be any guarantee that any of these
products will achieve any particular levels of revenue in the
future. Such forward-looking statements reflect the current views
of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results,
performance or achievements expressed or implied by such
statements. In particular, management's expectations regarding
these products could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
the Company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in
general; government, industry and general public pricing pressures;
the impact that the foregoing factors could have on the values
attributed to the Company's assets and liabilities as recorded in
its consolidated balance sheet, and other risks and factors
referred to in Sigma-Aldrich's current Form 10-K on file with the
US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected.
Sigma-Aldrich is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
About SAFC®: SAFC
is the custom manufacturing and services business unit of
Sigma-Aldrich Corporation. We are recognized as a top 10 global
fine chemical supplier and trusted manufacturer of specialty
chemicals and biologics for the life science and high technology
industries. Utilizing global "Centers of Excellence" and dedicated
manufacturing facilities, SAFC can often resolve development and
manufacturing challenges and accelerate the production of custom
materials. Our rich portfolio includes high-purity inorganic
materials for high technology applications, cell culture products,
services for biopharmaceutical manufacturing and biochemical
production, and complex, multi-step organic synthesis of APIs and
key intermediates. For more information about SAFC, visit
www.safcglobal.com.
About Sigma-Aldrich:
Sigma-Aldrich is a leading Life Science and
High Technology company. Its biochemical and organic chemical
products and kits are used in scientific and genomic research,
biotechnology, pharmaceutical development, the diagnosis of disease
and as key components in pharmaceutical and other high technology
manufacturing. The Company has customers in life science companies,
university and government institutions, hospitals, and in industry.
Over one million scientists and technologists use its products.
Sigma-Aldrich operates in 40
countries and has 8,300 employees providing excellent service
worldwide. Sigma-Aldrich is
committed to Accelerating Customer Success through Innovation and
Leadership in Life Science, High Technology and Service. For more
information about Sigma-Aldrich, please visit its award-winning web
site at www.sigma-aldrich.com.
SAFC and Sigma-Aldrich are registered trademarks of
Sigma-Aldrich Co. LLC. SafeBridge is a registered trademark of
SafeBridge Consultants, Inc.
SOURCE Sigma-Aldrich